Operations Compliance Specialist - CSS

Operations Compliance Specialist

Shift: Monday-Friday 8am-4pm
100% on-site

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year.

Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life‑enhancing and life‑saving treatments for patients annually.

The Operations Compliance Specialist provides technical and regulatory expertise to the investigation and deviation management process to ensure patient safety, regulatory compliance, and inspection readiness.

• Participate in and facilitate Rapid Response Team fact gathering
• Write Investigation reports – These written reports will clearly communicate what happened, why it happened, when it happened
• Propose CAPAs – how to prevent event from happening in the future
• Deploy industry-standard lean and six sigma tools to address the root causes of non-conforming quality events
• Facilitate cross-functional problem‑solving event
• Author SOPs and work instructions
• Review investigation documentation for OOS, OOT or atypical results, as well as deviations from regulations, corporate policy or site procedures
• Manage timelines for investigations/complaints to ensure that reporting is performed on time and investigations/complaints are addressed in a timely manner

• High School Diploma required
• Bachelor’s Degree desired or equivalent experience in the pharmaceutics industry
• Knowledge (minimum of 2 years) of pharmaceutical packaging and distribution processes, Standard Operating Procedures (SOPs) and Gx Ps
• Technical writing such as validation reports, engineering documents, controlled documents (SOPs, BRs, WIs) in a GxP environment (minimum of 1 year)
• Lean, Six Sigma, SPC experience (1 year preferred)
• Excellent oral and written communication skills
• Proactive problem‑solving and analytical skills
• Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time

• Competitive medical benefits and 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast‑paced work environment
• Opportunity to work on Continuous Improvement Processes

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life‑saving and life‑enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.

Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to Disabili This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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